Trial Outcomes & Findings for Surgery, Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer (NCT NCT00530634)

Last Updated: 2015-10-29

Results Overview

Estimated using the product-limit method of Kaplan and Meier. Progression defined as a 25% increase or an increase of 10 cm2 (whichever is smaller) in the sum of the products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation or death, or deteriorating condition (unless clearly unrelated to this cancer).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

2 years post-surgery

Results posted on

2015-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Gemcitabine + Cisplatin Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Surgery, Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine + Cisplatin n=3 Participants Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years post-surgery

Population: Study was terminated after accruing only three patients.

Outcome measures

Outcome measures
Measure	Gemcitabine + Cisplatin n=3 Participants Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
Two-year Progression-free Survival From the Date of Surgery	67.6 percentage of participants Interval 9.0 to The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

Adverse Events

Gemcitabine + Cisplatin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Gemcitabine + Cisplatin n=3 participants at risk Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
Blood and lymphatic system disorders Hemoglobin decreased	100.0% 3/3 • Number of events 10 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Lymphangiopathy NOS	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Lymphatic disorder	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Packed red blood cell transfusion	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Arrhythmia	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Cardiac disorder	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Conduction disorder	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Palpitations	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	66.7% 2/3 • Number of events 3 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Eye disorder	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 2 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophagitis	33.3% 1/3 • Number of events 2 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorder	66.7% 2/3 • Number of events 7 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 5 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chest pain	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	100.0% 3/3 • Number of events 5 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	66.7% 2/3 • Number of events 2 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders General symptom	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Oedema NOS	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	100.0% 3/3 • Number of events 9 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Radiation oesophagitis	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Number of events 3 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	66.7% 2/3 • Number of events 6 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukopenia	66.7% 2/3 • Number of events 5 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	33.3% 1/3 • Number of events 3 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	66.7% 2/3 • Number of events 2 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	33.3% 1/3 • Number of events 3 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	66.7% 2/3 • Number of events 3 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	66.7% 2/3 • Number of events 3 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	100.0% 3/3 • Number of events 4 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	66.7% 2/3 • Number of events 3 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 3/3 • Number of events 6 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	100.0% 3/3 • Number of events 5 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypomagnesemia	66.7% 2/3 • Number of events 4 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • Number of events 4 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Arthritis	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Bone pain	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	66.7% 2/3 • Number of events 3 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myositis	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Taste alteration	33.3% 1/3 • Number of events 2 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	66.7% 2/3 • Number of events 2 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urogenital disorder	66.7% 2/3 • Number of events 2 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 3/3 • Number of events 3 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	66.7% 2/3 • Number of events 4 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hiccough	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	66.7% 2/3 • Number of events 2 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	100.0% 3/3 • Number of events 4 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash desquamating	66.7% 2/3 • Number of events 2 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin disorder	66.7% 2/3 • Number of events 2 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	33.3% 1/3 • Number of events 2 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	33.3% 1/3 • Number of events 1 • Adverse events were recorded over a period of 46 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

Jeff Longmate, Ph.D.

City of Hope

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place